A Clinical Study of Pre and Post Vaccination Serology in Children Receiving the Seasonal Southern Hemisphere Formulation of Inactivated Influenza Vaccine

Women's and Children's Health Network0 个研究点目标入组 40 人开始时间: 2019年1月25日最近更新: 2019年2月4日

适应症

试验速览

暂无简介。

•Be healthy males or females, aged between 6 months and 9 years at the time of providing informed consent.
•Plan to be vaccinated with the seasonal Southern Hemisphere formulation of the Inactivated Influenza vaccine
•Have a parent able and willing to provide written informed consent for themselves and child.
•Able to understand, and willing and physically able to comply with study procedures.
•Be able to provide a sample of up to 3mL of venous blood pre-vaccination without undue distress/discomfort.

•Child has received any licensed or investigational vaccine or receiving any investigational product in the 28 days prior to taking Visit 1 blood sample;
•Child has a confirmed or suspected immunosupporessive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder including human immunodeficiency virus (HIV) infection at the time of study enrolment;
•Child has undergone chemotherapy or radiotherapy in the last 6 months at the time of study enrolment.
•The child currently (or within the last 90 days prior to blood collection) taking immunosuppressive or immunodulative medication, including systemic corticosteroids. Use of topical, inhalant or intra-articular corticosteroids is permitted prior to the study and during the on study period.
•Child has received immunoglobulin and/or blood product in the 28 days prior to taking Visit 1 blood sample.
•Parental or child participation in a clinical study that may interfere with participation in this study
•Anything that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study.

发起方

Women's and Children's Health Network